Preventing blood clots in critically ill children using enoxaparin

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The CRETE Studies aim to evaluate the effectiveness of enoxaparin, an anticoagulant, in preventing central venous catheter-associated deep venous thrombosis (CADVT) in critically ill children. This study recognizes the age-dependent differences in how children respond to this medication, particularly focusing on those aged 1-17 years. By comparing early administration of enoxaparin to standard care, the study seeks to confirm its efficacy and safety in reducing the risk of CADVT. The research is crucial as pediatric venous thromboembolism has significantly increased in recent years, and current prophylactic measures are limited due to a lack of age-specific evidence.

Why it matters

Who can join: the full rules

Inclusion criteria

1. \>36 weeks corrected gestational to \<17 years old
2. \<24 hours after insertion of an untunneled CVC
3. CVC inserted in the internal jugular or femoral vein

Exclusion criteria

1. Radiologic diagnosis of CADVT in the site of insertion in prior 6 weeks
2. Currently receiving an antithrombotic agent, e.g., LMWH, UFH, warfarin and aspirin, but not UFH at dose to maintain patency of a vascular catheter
3. Presence of clinically relevant bleeding, i.e., hemoglobin decreased ≥2 g/dl in 24 hours, required medical or surgical intervention to restore hemostasis, or in the retroperitoneum, pulmonary, intracranial or central nervous system, in the prior 60 days
4. Surgery in the prior 7 days
5. Major trauma in the prior 7 days
6. Presence of coagulopathy, i.e., INR \>2.0, aPTT \>50 seconds or platelet count \<50 x 10\^3/mcL
7. Presence of renal failure, i.e., creatinine clearance \<30 mL/min/1.73 m2
8. Known hypersensitivity to heparin or pork products
9. Laboratory confirmed HIT
10. Current pregnancy or lactation
11. Presence of an epidural catheter
12. Limitation of care
13. Previous enrollment in the CRETE Studies

Where it's running

• Children's of Alabama
  Birmingham, Alabama, United States Recruiting
• Arkansas Children's Hospital
  Little Rock, Arkansas, United States Recruiting
• Children's Hospital Colorado
  Aurora, Colorado, United States Recruiting
• Yale-New Haven Children's Hospital
  New Haven, Connecticut, United States Recruiting
• University of Florida -UF Health
  Gainesville, Florida, United States Recruiting
• Johns Hopkins All Children's
  St. Petersburg, Florida, United States Recruiting

Study contacts

• Principal investigator: E. Vincent Faustino, MD, MHS — Associate Professor of Pediatrics, Yale School of Medicine
• Study coordinator: E. Vincent Faustino, MD, MHS
• Email: vince.faustino@yale.edu
• Phone: 203-785-4651

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Blood test and software to guide treatment for venous thromboembolism

  This project tests whether a blood-based ctDNA test combined with a software risk score can predict if VTE will come back in adults with cancer-associated DVT or PE who have finished 3–12 months of anticoagulation.

  Recruiting at 7 sites Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 7 other locations · NCT07399977

• Comparison of ClotTriever System and Anticoagulation for Deep Vein Thrombosis

  This study is testing if the ClotTriever System can help people with painful deep vein blood clots feel better compared to the usual blood-thinning medications.

  Recruiting at 48 sites Inari Medical · Scottsdale, Arizona and 63 other locations · NCT05701917

• CHIPs-VTE program to prevent hospital-acquired blood clots in hospitalized patients

  This project tests whether a hospital-wide package of risk checks, computer alerts, staff education, and audits can increase appropriate clot-prevention for hospitalized patients in China.

  Recruiting China-Japan Friendship Hospital · Beijing, Beijing Municipality · NCT04211181

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.